NCT00281541

Brief Summary

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

First QC Date

January 23, 2006

Last Update Submit

June 6, 2012

Conditions

Melanoma

Keywords

Treatment EfficacyTreatment EffectivenessDisease ManagementTreatmentSafetyMalignant Melanoma

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate

    6 cycles

Secondary Outcomes (1)

  • Duration of response

    6 cycles

Interventions

YM155DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
  • Life expectancy \>12 weeks

You may not qualify if:

  • History of other malignancy in the last 5 years
  • Major surgery within the past 21 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Tuscon, Arizona, 85724, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Montclair, New Jersey, 07042, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

sepantronium

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • D. Buell, MD

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 25, 2006

Study Start

November 1, 2005

Study Completion

June 1, 2007

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

US(9)